FDA.reportPublic FDA data

Lidocaine 5%

Product NDC
60760-657
11-digit product format
607600657
Labeler code
60760
Product ID
60760-657_47d43f9a-dae8-595b-e063-6294a90aeb7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine 5%
Dosage form
PATCH
Route
TOPICAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA209190
Marketing category
ANDA
Marketing start
2023-06-15
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209190-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2020-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209190-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209190-001LIDOCAINE5%PATCH / TOPICALAB2020-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209190-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 5%LIDOCAINE 5%St. Mary's Medical Park Pharmacy052fa8a3-0e3c-d9c2-e063-6394a90aadd72026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
ndc (product): 60760-657
Lidox 5 PatchLIDOCAINE 5% PATCHInjecta Medcial LLC526b8681-098f-3410-e063-6294a90a79fb2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%YARAL Pharma Inc.fc495fc8-15d6-27c7-e053-6394a90ab30d2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
LidocanLIDOCAINE 5%PURETEK CORPORATIONfd8e4856-3785-4850-e053-6294a90a95b62026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%A-S Medication Solutionsfec1e759-60e4-47d4-bd54-947f18b103dd2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5% PatchLIDOCAINE 5%Medcore LLC1afe428f-e223-4ef8-a6ba-968f4cfbf4762026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Tridacaine IIILIDOCAINETrifluent Pharma LLC9b47102e-3b35-4aa7-a380-cd02ba9eac652025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Tridacaine XLLIDOCAINETrifluent Pharma LLC032b37a7-8a47-4809-a330-c76314225cbd2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%REMEDYREPACK INC.50152ae0-aebd-4a08-a5c7-c8858e0259972025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%Asclemed USA, Inc.1dca5b81-72a9-4969-8552-d43091f72aab2025-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VILIDOCAINE 5%PURETEK CORPORATION1b6dc518-a15b-1cf9-e063-6294a90a63572024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VIILIDOCAINE 5%PURETEK CORPORATION1f33d51c-168c-55f2-e063-6394a90a89052024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan IVLIDOCAINE 5%PURETEK CORPORATION137f9cc1-68c0-edcc-e063-6394a90abf6a2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan VLIDOCAINE 5%PURETEK CORPORATION141fe2bd-b25a-eff8-e063-6294a90a2ae82024-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocan IIILIDOCAINE 5%PURETEK CORPORATION07a258e4-4858-43b3-e063-6394a90a50842024-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190
Lidocaine 5%LIDOCAINE 5%NuCare Pharmaceuticals,Inc.1ac8a196-010f-a986-e063-6294a90a948f2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209190
application number: ANDA209190

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine 5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1745091Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
052fa8a3-0e3c-d9c2-e063-6394a90aadd7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-657-05Lidocaine 5%14 g in 1 POUCHPATCH143
60760-657-05Lidocaine 5%5 in 1 BAGPATCH53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-657-05EA - Each60760-657729f3f10-5ba0-4385-af97-a58600acb5c612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-657LIDOCAINE 5% PATCH [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, 2 package rows20250124_052fa8a3-0e3c-d9c2-e063-6394a90aadd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN052fa8a3-0e3c-d9c2-e063-6394a90aadd73
1745091lidocaine 0.05 MG/MG Medicated PatchSCD052fa8a3-0e3c-d9c2-e063-6394a90aadd73
1745091lidocaine 5 % Medicated PatchSY052fa8a3-0e3c-d9c2-e063-6394a90aadd73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-657-05607600657055 POUCH in 1 BAG (60760-657-05) / 14 g in 1 POUCH5 pouch2023-08-30NoNoCurrent